Labeling Specialist, Global Supply Chain

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 74,000 - 104,000; Full time

Job summary

Edwards Lifesciences Gruppe in Irvine, CA, is seeking a dedicated Labeling Specialist to join our Global Operations & Quality team. You will drive labeling activities, collaborate across manufacturing operations and sales, and ensure timely, compliant labeling deliverables for our cardiovascular devices.

The role requires a Bachelor's degree and 3 years of related experience in a regulated medical environment, along with strong communication, project management, and problem-solving skills.

Qualifications

• Bachelor's degree required with 3+ years in a device/medical FDA-regulated setting.
• Strong written and verbal communication and cross-functional collaboration.
• Experience reading and applying labeling standards and change control workflows.

Responsibilities

• Drive labeling activities and project outcomes across cross-functional teams.
• Define labeling change request requirements with design content and artifacts.
• Review workflows to align with labeling quality systems and milestones.
• Coordinate translation projects and manage vendor communications.
• Lead process-improvement initiatives and provide training as needed.
• Resolve SCARs, NCRs and CAPAs; support risk assessment activities.

Skills

Leadership

Problem-solving

Communication skills

Attention to detail

Education

Bachelor's degree

Tools

MS Office Suite

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Labeling Specialist position is a unique career opportunity that could be your next step towards an exciting future.Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.How you’ll make an impact:Apply professional expertise and judgment to drive labeling activities and business outcomes.Identify solutions for the Clinical, NPD and Sustaining labeling change request requirements including:Provide definition to the requestor and cross-functional representatives with labeling design requirements while establishing agreement on content, format and artifact (e.g., IFUs, Labels, and Implant Cards) solutions for moderately complex labeling change packagesReview workflow expectations and milestones to achieve results to ensure alignment with business strategy, comply with labeling quality systems and meet customer expectations with ability to reach consensus on priorities and target completion dates.Identify, evaluate, make recommendations and execute labeling change request tasks to assure alignment with project solution and requested target dates.Provide recommendations and regular report out on activities and issues resolution of various business scenarios. Prepare, review and approve labeling intake documentation. Provide guidance to labeling team on identification and execution of typical solutions with accelerate timetables for critical projects.Develop and maintain timetables for creation of new and revisions to existing labeling content and format in a cost-effective manner. Partner with team members to ensure label change package execution aligns with project deliverables.Partner with vendors on translation projects, preparing content and coordinating internal and external communications to meet timelines. Proactively identify translation issues, drive resolution, and manage translation project workflows.Lead sections of process improvement projects and propose solutions. Identify and define gaps, revise verbiage to clarify, improve/enhance and/or correct relevant procedures and provide guidance and training as needed.Provide support to resolve SCARs, NCRs, non-conformances and CAPAs (e.g., process owners). Apply statistically based data research and analysis methods and techniques to identify root causes and corrective actions.On time completion of training requirements for this position, assist with knowledge and skill transfer to team members. Assist with creation and maintenance labeling process playbook and provide content and format training for team members and stakeholders.Evaluate and assess risks, identify options to resolve critical path issuesOther incidental dutiesWhat you’ll need (Required):Bachelor's Degree with 3 years of related work experience in a device/medical/pharmaceutical FDA regulated industry or equivalent work experience based on Edward's criteriaWhat else we look for (Preferred):Good computer skills including usage of MS Office SuiteExcellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skillsAbility to establish grammatical and formatting conventions, templates and style guidesGood leadership and influence skills, with a demonstrated ability to lead change and drive adoption of improved processes and solutions.Experience managing tasks of projectsAble to read, comprehend, write, and speak EnglishModerate understanding of domestic and global development and implementation of labelingModerate understanding of medical and/or pharmaceutical regulations and standardsModerate knowledge of medical device documentation development activitiesWork effectively within change control and quality management processes to manage labeling changes and quality events.Good problem-solving, organizational, analytical and critical thinking skillsGood project management skillsStrict attention to detailAbility to build productive internal/external working relationshipsAdhere to all company rules and requirements (e.g. Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $74,000 to $104,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.